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AnalgesiaNCT04908761

Quadratus Lumborum Block After Living Donor Kidney Transplantation

A study testing Transmuscular quadratus lumborum block in people with Analgesia, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to evaluate the postoperative analgesic effect of quadratus lumborum block in patient undergoing a living donor kidney transplant under general anesthesia. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Analgesia
What is being tested?
Transmuscular quadratus lumborum block
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
1 siteSouth Korea
Study dates
3 Jun 2021to 28 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients over 19 years of age undergoing elective living donor kidney transplantation under general anesthesia in Seoul National University Hospital

Who cannot join

  • Patients with severe pain before surgery
  • Patients with a history hypersensitivity reactions on fentanyl or ropivacaine
  • Patients who cannot maintain patient-controlled analgesia (PCA) by themselves
  • ④ Patients with skin diseases or infections in the area where quadratus lumborum block is applied
  • ⑤ Any other cases that researchers determine that it is inappropriate for this clinical trial

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

Official title: Quadratus Lumborum Block for Analgesia After Living Donor Kidney Transplantation: A Randomized Controlled Trial

The aim of this study is to evaluate the postoperative analgesic effect of quadratus lumborum block in patient undergoing a living donor kidney transplant under general anesthesia.

Read the detailed description

The purpose of this study was to investigate whether postoperative pain is significantly reduced when TQL block was additionally performed after surgery in patients undergoing living-donor kidney transplantation. Therefore, investigator hypothesized that the analgesic consumption for postoperative 24 hours will decrease in TQL group compared to the control group. For secondary outcomes, the pain score at rest/ movement up to 48 hours after surgery, the time until the first pain reliever is requested, whether and how often rescue analgesics are administered for 48 hours, the incidence and severity of nausea and vomiting during the 48 hours after surgery, patient's satisfaction with post-pain control and the number of hospital stays were investigated. Overall, the aim of this study is to evaluate the postoperative analgesic effect of quadratus lumborum block in patients undergoing a living donor kidney transplantation under general anesthesia.

Conditions
Analgesia
Being tested
Transmuscular quadratus lumborum block, Placebo
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transmuscular quadratus lumborum blockProcedure or surgery

    Patients assigned to the TQL block group receive the TQL block in a supine position with the surgical site facing up before recovery of general anesthesia after surgery. For the block, 30cc of 0.375% ropivacaine is used.

  • PlaceboProcedure or surgery

    For patients assigned to the control group, 30cc of 0.9% normal saline is used for TQL block.

Study groups in NCT04908761
Study groupRoleWhat they receive
Transmuscular quadratus lumborum block groupExperimentalPatients assigned to the Transmuscular Quadratus Lumborum (TQL) block group receive the Transmuscular Quadratus Lumborum block in a lateral decubitus position with the surgical site facing up before recovery of general anesthesia after surgery. For the block, 30cc of 0.375% ropivacaine is used.
Receives: Procedure: Transmuscular quadratus lumborum block
Control groupPlacebo comparatorFor patients assigned to the control group, 30cc of 0.9% normal saline is used for Transmuscular Quadratus Lumborum block.
Receives: Procedure: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Analgesic consumption for 24 postoperative hours

    Total analgesic use for 24 hours after surgery (morphine milligram equivalents (MME))

    Measured: 24 hours postoperatively

Secondary outcomes (12)

  1. Analgesic consumption

    Analgesic consumption at postoperative 6, 12, 48 hours

    Measured: at postoperative 6, 12, 48 hours

  2. Resting pain numeric rating scale(NRS)

    Resting pain numeric rating scale(NRS) at postoperative 6, 12, 24, 48 hours. Numeric rating scare is 11-point scale from 0 to 10, The higher the number, the more severe the pain (0 is no pain at all, 10 is the most severe pain imaginable).

    Measured: at postoperative 6, 12, 24, 48 hours

  3. Numeric rating scale of pain during movement

    Numeric rating scale of pain during movement at postoperative 6, 12, 24, 48 hours Numeric rating scare is 11-point scale from 0 to 10. The higher the number, the more severe the pain (0 is no pain at all, 10 is the most severe pain imaginable).

    Measured: at postoperative 6, 12, 24, 48 hours

  4. Time to first rescue analgesics

    Time to first rescue analgesics

    Measured: within post-operative 24 hours

  5. Numeric rating scale at post anesthetic care unit (PACU)

    Numeric rating scale at post anesthetic care unit Numeric rating scare is 11-point scale from 0 to 10. The higher the number, the more severe the pain (0 is no pain at all, 10 is the most severe pain imaginable).

    Measured: 30 minutes after the end of operation

  6. Rescue analgesics administration

    Rescue analgesics administration count

    Measured: within post-operative 48 hours

  7. The incidence of post-operative nausea and vomiting

    The incidence of post-operative nausea and vomiting

    Measured: within post-operative 48 hours

  8. Patient satisfaction with pain control

    Patient satisfaction with pain control in 11 point scale (0-10), The higher the score, the higher the patient's satisfaction.

    Measured: At post-operative 48 hours

  9. Pattern of injectate spread on ultrasonography

    Pattern of injectate spread on ultrasonography

    Measured: During procedure quadratus lumborum (QL) block

  10. Sensory blockade

    After surgery, an alcohol swab is used to evaluate the loss of cold sensation. It is evaluated by dividing into nine regions bordering the rib margin on the side of the surgery, the horizontal line passing through the umbilicus and pubis, and the vertical line of the midclavicular line, anterior axillary line, and mid axillary line. If cold sensation is the same as the opposite part of the regions, marked as 2 points, if decreased marked as 1 point, and if not sensed at all, marked as 0 point.

    Measured: 30 minutes after the end of operation

  11. Quality of Recovery Questionnaire (15-item Quality of Recovery)

    Each item uses an 11-point numeric rating scale. The sum of the scores of the 15 items ranges from 0 to 150, with a high score indicating good quality of recovery.

    Measured: At post-operative 48 hours

  12. The severity of post-operative nausea and vomiting

    The severity of post-operative nausea and vomiting, The severity of the nausea and vomitting is asked to patient and expressed as none, mild, or severe.

    Measured: within post-operative 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2021
  2. Study start3 Jun 2021
  3. Primary completion18 May 2022
  4. Study completion28 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single center, double-blind, randomized controlled trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04908761
Sponsor's protocol ID
2104-083-1211
Status last verified
Dec 2022
First submitted
20 May 2021
Last updated
27 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yang P, Luo Y, Lin L, Zhang H, Liu Y, Li Y. The efficacy of transversus abdominis plane block with or without dexmedetomidine for postoperative analgesia in renal transplantation. A randomized controlled trial. Int J Surg. 2020 Jul;79:196-201. doi: 10.1016/j.ijsu.2020.05.073. Epub 2020 Jun 2.

    PubMed 32502705

  • Territo A, Mottrie A, Abaza R, Rogers C, Menon M, Bhandari M, Ahlawat R, Breda A. Robotic kidney transplantation: current status and future perspectives. Minerva Urol Nefrol. 2017 Feb;69(1):5-13. doi: 10.23736/S0393-2249.16.02856-3. Epub 2016 Nov 30.

    PubMed 28009142

  • Kruszyna T, Niekowal B, Krasnicka M, Sadowski J. Enhanced Recovery After Kidney Transplantation Surgery. Transplant Proc. 2016 Jun;48(5):1461-5. doi: 10.1016/j.transproceed.2015.11.037.

    PubMed 27496428

  • Freir NM, Murphy C, Mugawar M, Linnane A, Cunningham AJ. Transversus abdominis plane block for analgesia in renal transplantation: a randomized controlled trial. Anesth Analg. 2012 Oct;115(4):953-7. doi: 10.1213/ANE.0b013e3182642117. Epub 2012 Jul 4.

    PubMed 22763899

  • Rohan VS, Taber DJ, Patel N, Perez C, Pilch N, Parks S, Bolin E, Nadig SN, Baliga PK, Fleming JN. Impact of a multidisciplinary multimodal opioid minimization initiative in kidney transplant recipients. Clin Transplant. 2020 Oct;34(10):e14006. doi: 10.1111/ctr.14006. Epub 2020 Sep 4.

    PubMed 32524643

  • de Boer HD, Detriche O, Forget P. Opioid-related side effects: Postoperative ileus, urinary retention, nausea and vomiting, and shivering. A review of the literature. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):499-504. doi: 10.1016/j.bpa.2017.07.002. Epub 2017 Jul 8.

    PubMed 29739538

  • Jun JH, Kim GS, Lee JJ, Ko JS, Kim SJ, Jeon PH. Comparison of intrathecal morphine and surgical-site infusion of ropivacaine as adjuncts to intravenous patient-controlled analgesia in living-donor kidney transplant recipients. Singapore Med J. 2017 Nov;58(11):666-673. doi: 10.11622/smedj.2017077. Epub 2017 Aug 14.

    PubMed 28805236

  • Korgvee A, Junttila E, Koskinen H, Huhtala H, Kalliomaki ML. Ultrasound-guided quadratus lumborum block for postoperative analgesia: A systematic review and meta-analysis. Eur J Anaesthesiol. 2021 Feb 1;38(2):115-129. doi: 10.1097/EJA.0000000000001368.

    PubMed 33186305

  • Uppal V, Retter S, Kehoe E, McKeen DM. Quadratus lumborum block for postoperative analgesia: a systematic review and meta-analysis. Can J Anaesth. 2020 Nov;67(11):1557-1575. doi: 10.1007/s12630-020-01793-3. Epub 2020 Aug 17.

    PubMed 32808097

  • Kim Y, Kim JT, Yang SM, Kim WH, Han A, Ha J, Min S, Park SK. Anterior quadratus lumborum block for analgesia after living-donor renal transplantation: a double-blinded randomized controlled trial. Reg Anesth Pain Med. 2024 Aug 5;49(8):550-557. doi: 10.1136/rapm-2023-104788.

    PubMed 37704438

Questions about this trial

What is this clinical trial studying?

A study testing Transmuscular quadratus lumborum block in people with Analgesia, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analgesic consumption for 24 postoperative hours (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04908761, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.

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